K151104 is an FDA 510(k) clearance for the OTELO LL. This device is classified as a Retractor (Class I - General Controls, product code GAD).
Submitted by Spineart (Geneva, CH). The FDA issued a Cleared decision on January 6, 2016, 257 days after receiving the submission on April 24, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K151104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2015 |
| Decision Date | January 06, 2016 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAD — Retractor |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |